FDA Approves Abbott's Tendyne Transcatheter Mitral Valve Replacement System To Treat People With Mitral Valve Disease

• The Tendyne system replaces mitral valves that are not functioning properly due to a buildup of calcium in the base of the valves, known as severe mitral annular calcification (MAC)
• Tendyne offers a new treatment option for patients who are not candidates for open-heart surgery or mitral repair
• This approval expands Abbott's portfolio of minimally invasive structural heart therapies in the U.S.

ABBOTT PARK, Ill., May 27, 2025 /PRNewswire/ -- Abbott (NYSE:ABT) today announced the U.S. Food and Drug Administration (FDA) has approved the company's Tendyne™ transcatheter mitral valve replacement (TMVR) system to treat people with mitral valve disease. This life-changing therapy is available for patients whose mitral valves are not functioning properly due to severe mitral annular calcification (MAC), a buildup of calcium within the ring-like structure (known as an annulus) that supports the mitral valve.

The complex nature of mitral valve disease and patients' specific needs and health conditions can pose challenges for surgical correction. For patients with severe MAC who are at high risk for open-heart surgery and whose mitral valve cannot be successfully repaired with the Abbott MitraClip™ device, Tendyne offers an alternative minimally invasive way to replace the valve that's leaky (mitral regurgitation) or narrowed (stenosis).